DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-10 and 13-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (naturally occurring products) without significantly more. The claim(s) recite(s) compositions comprising sulodexide and one or more flavonoids. Both of these compounds are seen to be products of nature, as are various additional agents such as water which would be used to make a solution of claim 5. This judicial exception is not integrated into a practical application because the claims do not recite any additional elements to amount to significantly more. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there is no indication that the purification or combination of agents have any characteristics that are not present in the compounds as they naturally occur.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Gonzalez Ochoa et al. (International Angiology, vol. 36(1), pp 82-87 – NPL reference NPL3 from applicant’s IDS filed 6/7/24).
The claims of the present application are drawn to compositions for oral use comprising sulodexide and one or more flavonoids. The flavonoids are limited to flavones, and ultimately to diosmin in an amount of between 350-520mg, or 450mg. The sulodexide is limited to an amount of between 21-29mg, or 25mg. The compositions are taught to be in the form of a tablet, capsule, suspension, emulsion, or solution. Also claimed are methods of treating vascular diseases such as chronic venous insufficiency with the same.
Gonzalez Ochoa et al. teach methods of treating venous ulcers in their vascular disease clinic comprising administering 450mg diosmin tablets and 25mg sulodexide tablets orally starting on day 11. As such, Gonzalez Ochoa et al. teaches to administer the same combination of drugs in the same amounts in the same oral form to treat the same diseases as claimed herein. What was not disclosed as administering the two compounds in a single composition.
It would have been prima facia obvious to combine the active agents in Gonzalez Ochoa et al., namely sulodexide and diosmin, in the same amounts used therein, and administer them as a single dosage composition. One would have been motivated to combine the agents to afford an easier dosing protocol of administering one tablet instead of two. It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in the prior art. In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious). In the instant case, Gonzalez Ochoa et al. teach to combine the medications as they do the same in their therapy by administering the two drugs in the same amounts as claimed herein to the same population and produced the same results as claimed herein.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRAVISS C MCINTOSH III whose telephone number is (571)272-0657. The examiner can normally be reached Monday-Friday 9AM-5:30PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached at 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TRAVISS C MCINTOSH III/ Primary Examiner, Art Unit 1693
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